[Federal Register Volume 78, Number 136 (Tuesday, July 16, 2013)]
[Notices]
[Pages 42530-42531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16949]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive License: Human Papillomavirus 
16 E2 and E6 Peptides for Cervical Cancer Vaccine Development

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health (NIH), Department of 
Health and Human Services, is contemplating the grant of an exclusive 
worldwide license to practice the inventions embodied in:

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                                          Patent                                               Issued patent no.
           NIH Ref. No.              application No.                 Filing date                    (if any)
----------------------------------------------------------------------------------------------------------------
NIH Ref. E-126-2001/0-AU-06.......         2002258614  March 22, 2002........................         2002258614
NIH Ref. E-126-2001/0-CA-04.......            2441947  March 22, 2002........................  .................
NIH Ref. E-126-2001/0-EP-05.......          2728570.9  March 22, 2002........................  .................
NIH Ref. E-126-2001/0-PCT-02......     PCT/US02/09261  March 22, 2002........................          (Expired)
NIH Ref. E-126-2001/0-US-01.......         60/278,520  March 23, 2001........................          (Expired)
NIH Ref. E-126-2001/0-US-03.......         10/472,661  September 23, 2003....................          7,189,513
NIH Ref. E-126-2001/0-US-07.......         11/685,632  March 13, 2007........................          7,507,538
NIH Ref. E-155-2005/0-US-01.......         60/671,463  April 15, 2005........................          (Expired)
NIH Ref. E-155-2005/1-US-01.......         60/680,000  May 12, 2005..........................          (Expired)
NIH Ref. E-155-2005/2-US-01.......         60/724,783  October 11, 2005......................          (Expired)
NIH Ref. E-155-2005/3-AU-04.......         2006236905  April 11, 2006........................  .................

[[Page 42531]]

 
NIH Ref. E-155-2005/3-CA-05.......            2604909  April 11, 2006........................  .................
NIH Ref. E-155-2005/3-EP-03 (CH,            6749659.6  April 11, 2007........................            1877087
 DE, FR, GB, and IE).
NIH Ref. E-155-2005/3-PCT-01......    PCT/US2006/1331  April 11, 2006........................          (Expired)
NIH Ref. E-155-2005/3-US-02.......         11/918,557  October 11, 2006......................          7,691,579
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to Georgia Health Sciences University Research Institute, Inc. having a 
principal place of business in Augusta, Georgia.
    The United States of America is an assignee to the patent rights of 
these inventions.
    The contemplated exclusive license may be in a field of use 
directed to cervical cancer vaccines.

DATES: Only written comments and/or applications for a license that are 
received by the NIH Office of Technology Transfer on or before August 
15, 2013 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Michael Shmilovich, Esq, CLP, Senior Licensing 
and Patent Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5019; Facsimile: (301) 402-0220; Email: 
[email protected]. A signed confidential disclosure agreement may be 
required to receive copies of patent applications assuming it has not 
already issued or been published under either the publication rules of 
either the US Patent and Trademark Office or World Intellectual 
Property Organization.

SUPPLEMENTARY INFORMATION:

NIH Ref. No. E-155-2005/0-3 (as Above)

    The invention pertains primarily to CD8+ T cell epitopes from HPV16 
E2. These epitopes generated from amino acid positions 69-77 
(ALQAIELQL) and 138-147 (YICEEASVTV) bind to HLA.A2 and elicit CD8+ 
cytotoxic T cell responses that lyse tumor cells of low-grade cervical 
neoplasia (wart).

NIH Ref. No. E-126-2001/0 (as Above)

    Immunogenic peptides from the HPV-18E6 
(X1KLPDLCTELX2;, wherein X2 and 
X1 are peptides of 0-11 amino acids in length comprising 
contiguous HPV 18 E6 amino acid sequences) protein that comprise class 
I restricted T cell epitopes and methods of administering the same. The 
HPV-18E6 peptide cross-reacts immunologically with both HPV type 16 and 
HPV type 18 with higher affinity than most common human lymphocyte 
antigen (HLA), HLA-A2 than the homologous peptide from HPV 16. E6 
peptide vaccines are potentially prophylactic or therapeutic for 
cervical cancer, other genital cancers, head and neck cancers, and 
upper digestive tract cancers. It could also be potentially used in the 
treatment of patients presenting with pre-malignant cervical disease, 
especially in underdeveloped countries with no access to surgical 
treatment or to completely avoid surgical treatment.
    The prospective exclusive license will be royalty-bearing and 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 
404. The prospective exclusive license may be granted unless, within 
thirty (30) days from the date of this published notice, NIH receives 
written evidence and argument that establishes that the grant of the 
license would not be consistent with the requirements of 35 U.S.C. 209 
and 37 CFR part 404.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response to 
this notice will not be made available for public inspection, and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: July 9, 2013.
Richard Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-16949 Filed 7-15-13; 8:45 am]
BILLING CODE 4140-01-P